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Breast NeoplasmNCT04440995

The Effects of Perioperative PECS Block During Robotic Breast Surgery and Breast Reconstruction

A study testing pectoral nerve block in people with Breast Neoplasm, run by Yonsei University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pectoral nerve blocks (PECS blok) are used in postoperative analgesia after breast surgery in nowadays. Many studies shows that pectoral nerve blocks is effective for reducing pain and postoperative opioid consumption undergoing mastectomy. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Breast Neoplasm
What is being tested?
pectoral nerve block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSouth Korea
Study dates
8 Jul 2020to 10 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 20years or older
  • Scheduled for robot-assisted nipple-sparing mastectomy with immediate gel implant or tissue expander breast reconstruction
  • American Society of Anesthesiologists(ASA) physical status I and III

Who cannot join

  • Emergency operation
  • Reoperation
  • Patients with local anesthetic allergy
  • Patients with coagulopathy
  • Patients on anticoagulants
  • Patients who cannot use patient controlled analgesia(PCA)
Show all 14Show fewer
  • Patients with morbid obesity [body mass index (BMI) >35 kg/m2]
  • Patients with history of uncontrolled hypertension (diastolic BP >110mmHg) or DM
  • Patients with history of heart failure (unstable angina, congestive heart failure)
  • Patients with history of liver failure, renal failure, allergic to medicine
  • Patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia)
  • Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression)
  • Patients who cannot read the consent form (examples: Illiterate, foreigner)
  • Patients who withdraw the consent

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Yonsei Severance Hospital

    Seoul

Other trials in South Korea

About this study

Official title: The Effects of Perioperative PECS Block on Postoperative Pain Control During Robotic Breast Surgery and Breast Reconstruction - Double Blind Randomized Controlled Trial -

Pectoral nerve blocks (PECS blok) are used in postoperative analgesia after breast surgery in nowadays. Many studies shows that pectoral nerve blocks is effective for reducing pain and postoperative opioid consumption undergoing mastectomy. This study was planned to evaluate the efficacy of intraoperative PECS block for postoperative analgesia after robot breast surgery and immediate breast reconstruction.

Read the detailed description

Sixty patients were randomly allocated into two groups by computerised process, each including 30 patients. PECS group (P) received general anesthesia and pectoral nerve block(PECS block) with 025% ropivacaine after surgical resection of breast by operator. Control group(C) only received general anesthesia.

A Patient -controlled analgesia(PCA) device provides fentanyl for postoperative pain control.

The Primary outcome measures total dose of fentanyl consumption during the postoperative 24 hours, and secondary outcome measures pain scores at rest and movement.

Conditions
Breast Neoplasm
Being tested
pectoral nerve block
Keywords
breast neoplasms
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pectoral nerve blockProcedure or surgery

    Patients received standardized general anesthesia. PECS block were applied under vision using blunted tip cannula(27G, 30mm) after surgical resection of breast by operator. 0.25% ropivacaine 10ml was injected into fascia between pectoralis major and minor muscles. 0.25% ropivacaine 20ml was injected into fascia between pectoralis minor and serratus anterior muscles at the level of the third rib. Breast reconstruction is performed after PECS block

Study groups in NCT04440995
Study groupRoleWhat they receive
PECS block(P) groupExperimentalPECS group (P) received general anesthesia and pectoral nerve block(PECS block) with 025% ropivacaine after surgical resection of breast by operator.
Receives: Procedure: pectoral nerve block
Control(c) groupNo interventiononly received general anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total dose of fentanyl consumption during the postoperative 24h

    To evaluate the effect of PECS block undergoing robot-assisted nipple-sparing mastectomy (RANSM) with immediate breast reconstruction (IBR), total cumulative dose of fentanyl was measured for the first postoperative 24h

    Measured: after 24 hours postoperative period

Secondary outcomes (18)

  1. a numeric rating score at rest

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

    Measured: 0 hour after surgery

  2. a numeric rating score at rest

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

    Measured: 0.5 hour after surgery

  3. a numeric rating score at rest

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

    Measured: 1 hour after surgery

  4. a numeric rating score at rest

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

    Measured: 2 hours after surgery

  5. a numeric rating score at rest

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

    Measured: 4 hours after surgery

  6. a numeric rating score at rest

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

    Measured: 6 hours after surgery

  7. a numeric rating score at rest

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

    Measured: 8 hours after surgery

  8. a numeric rating score at rest

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

    Measured: 12 hours after surgery

  9. a numeric rating score at rest

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

    Measured: 24 hours after surgery

  10. a numeric rating score at movement

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

    Measured: 0 hour after surgery

  11. a numeric rating score at movement

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

    Measured: 0.5 hour after surgery

  12. a numeric rating score at movement

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

    Measured: 1 hour after surgery

  13. a numeric rating score at movement

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

    Measured: 2 hours after surgery

  14. a numeric rating score at movement

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

    Measured: 4 hours after surgery

  15. a numeric rating score at movement

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

    Measured: 6 hours after surgery

  16. a numeric rating score at movement

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

    Measured: 8 hours after surgery

  17. a numeric rating score at movement

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

    Measured: 12 hours after surgery

  18. a numeric rating score at movement

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

    Measured: 24 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2020
  2. Study start8 Jul 2020
  3. Primary completion10 Oct 2021
  4. Study completion10 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04440995
Sponsor's protocol ID
4-2020-0430
Status last verified
Nov 2021
First submitted
18 Jun 2020
Last updated
17 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing pectoral nerve block in people with Breast Neoplasm, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total dose of fentanyl consumption during the postoperative 24h (time frame: after 24 hours postoperative period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04440995.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.

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